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China VC Watch: Genome, Diagnostics Ventures Attract New Funding

Genetron Health is the latest emerging Chinese biotech to attract new capital in the push toward precision medicine in China, while the Lilly Asia Fund is among the investors in cancer diagnosis venture Singlera’s Series A.

China StartUps and SMEs In Vitro Diagnostics

US FDA Agrees To CLIA Waiver Process Reforms, But More Is Needed, Coalition Says

Despite FDA's efforts to centralize CLIA waiver reviews and bring more consistency to the process, one reform group tied to the diagnostics industry says the agency is not addressing the real problem: the fundamental standard for a waiver determination that FDA established in a 2008 guidance.

In Vitro Diagnostics Policy and Regulation Legislation

Robert Byrne: Absorb, Synergy, And The Future Of Coronary Stents

One of the most controversial, and potentially impactful, questions in medical device development today is how to better prevent late events, especially late stent-thrombosis, in coronary stent patients. The two leading answers to this question are a completely bioresorbable drug-eluting stent and a metal drug-eluting stent with a bioresorbable polymer, but there may be even more ideas on the horizon. One of the leading experts in the field and a cardiologist with experience with most of these new technologies, Robert Byrne of Deutsches Herzzentrum in Munich, recently talked to Medtech Insight about the questions that still need to be answered in this field and how it can move forward.

Cardiovascular Innovation Clinical Trials

Podcast: Mark McClellan Explains New NEST Recommendations

In this interview, Mark McClellan, the Duke-Margolis Center director and health-policy expert, discusses new planning-board proposals for the National Evaluation System for health Technology, which US FDA envisions as a paradigm shift for device data collection.

Medical Device Regulation Policy and Regulation
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Policy & Regulation

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Sen. Alexander Wants To ‘Start From Scratch’ In Regulating Lab-Developed Tests

Senate HELP Committee Chair Lamar Alexander, R-Tenn., suggested he would prefer to “start from scratch” in developing appropriate regulatory controls for laboratory-developed tests, despite a proposed regulatory framework for US FDA for the tests that was more than a decade in the making. That triggered some debate at a Sept. 20 committee hearing.

In Vitro Diagnostics Policy and Regulation Regulation

QUALITY REPLAY: Walking The Document Control Tightrope – How Manufacturers Can Toe The Line

From our digital archives: Document control violations typically occur when manufacturers don’t have procedures or fail to ensure that document changes are applied systemically, FDA says. Experts also advise firms to schedule periodic document reviews and have a centralized document control group. “Don’t assume that everyone knows about document control,” says Karen St. Onge, a QA official at NxStage Medical.

Quality Control Policy and Regulation Regulation

Latest From Policy and Regulation

US House Members Urge Hearings On Device Safety

A bipartisan coalition of seven members of the US House asked Energy and Commerce Committee leaders to hold hearings on medical device safety, trying to bring more attention to provisions that might strengthen safety oversight amid all the talk of accelerating medical innovation.

Legislation Policy and Regulation

Podcast: Regs May Be Warranted To Protect Shared Medtech Data

The CEO of the National Organization for Rare Disorders spoke with Medtech Insight at the Medical Device Innovation Consortium 2016 Public Forum. Peter Saltonstall said regulatory steps may be needed to support efforts to get companies to share clinical data to support precision medicine and a National Evaluation System for health Technology.

Policy and Regulation Innovation

Deadline Reprieve Mooted For Russian Registration Replacements

Medtech companies are being warned that if they do not renew their registration certificates in Russia by the start of 2017, their certificates will become invalid.

Russian Federation Regulation

FDA Panel Supports Class II For Wound Dressings, But More Controls When Antibiotics Are Added

Most experts on US FDA’s General & Plastic Surgery Devices Advisory Committee recommended Sept. 21 that drug-containing wound dressings should be placed in the class II risk category, but some pushed for more oversight of products containing antibiotics, with some panelists recommending class III placement in those instances.

Policy and Regulation Regulation

€20m Action Tackles Poor Uptake Of Joint HTAs Across Europe; Commission Consultation Nears

Europe’s EUnetHTA collaboration is working on producing a raft of new joint HTA reports for medical device and drug developers, and it is planning to facilitate 35 early dialogues between HTA bodies and manufacturers. It is also exploring why only a few European countries are making full use of the reports it has produced so far. Meanwhile, the European Commission is gearing up to consult extensively on how to create a sustainable network for HTAs across Europe.

Europe Health Technology Assessment

Clinical Trial Design, Precision Medicine Added To CDRH Science Priorities

US FDA's device center issued its third annual regulatory science priorities list, adding emphasis on clinical trial designs, and precision medicine and biomarkers, while dropping human-factors engineering from the list.

Policy and Regulation Innovation

Commercial

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GE Will Back Start-Ups Shooting For Improved Global Health

GE Healthcare has launched a health-care accelerator program to support global-health start-ups aiming to improve health-care quality and accessibility in developing economies.

StartUps and SMEs Financing Innovation

Latest From Commercial

Five Charged In $20m Embezzlement At Hearing Aid Company

Three former executives at hearing aid company Starkey Laboratories, along with two outside conspirators, are facing federal fraud, conspiracy and money-laundering charges. The defendants reportedly stole more than $20m via a complicated web of sham companies between 2006 and 2015.

United States Commercial

AMS Seeks To Stitch In More M&A Deals

Advanced Medical Solutions is on the hunt for acquisition opportunities to grow its wound-care business following a 20% increase in revenue during the first half of 2016.

Wound Management Financial Reports

Plaintiff Gets New Trial In Boston Sci Mesh Case

A Massachusetts state appeals court sent a verdict favoring the company back to the county court for reconsideration. The higher court found the judge in the original case acted improperly by keeping information relevant to mesh safety concerns from the jury.

Legal Commercial

Edwards, Boston Sci Make TAVR Progress In Europe

Edwards Lifesciences' Sapien 3 transcatheter aortic heart valve is now labeled in Europe for use in patients who face an intermediate risk from open-heart surgery, matching a recent US development. Meanwhile, Boston Scientific's next-generation Lotus Edge TAVR device gained a CE mark.

Medical Device Cardiology

Device Week – September 19, 2016

On this week's podcast, Tina Tan and David Filmore discuss the ophthalmology market; in particular, Tina's recent interview with James Mazzo, and the planned sale of Abbott Medical Optics to Johnson & Johnson for more than $4bn.

Medical Device Ophthalmic

New Vibration Tech Holds Promise For Early Diabetic Neuropathy Detection

Early positive results from a Swedish study points to the potential of a multi-frequency vibrometry device as a tool for early detection of diabetic foot ulcers.

Diabetic Care Innovation

Clinical R&D

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Expert Webinar Explores Pressing Questions About Biosorbable Stent Technology

Boston Scientific and inVentive Health recently sponsored a webinar with four internationally well-known experts on coronary stent technology to discuss the pros and cons of new bioabsorbable polymer stent technologies – both the fully resorbable stents and metal drug-eluting stents with a bioresorbable polymer. Here's a summary of the discussion. Medtech Insight is also providing a complete transcript of the event.

Cardiovascular Innovation Clinical Trials

Latest From Research and Development

Medtronic Artificial Pancreas Trial Results Published

Medtronic’s Hybrid closed-loop system is safe and improves some key patient outcomes, according to results published in the Journal of the American Medical Association. The system is currently before FDA for review.

Research and Development Medical Device

FDA Issues How-To On Computational Modeling Reports

The document, which finalizes a 2014 draft guidance, details 15 key areas device-makers should include in device-submission reports on computer modeling and simulation.

United States Research and Development

Robotic Arm Inventor Says 18 Months ‘Too Long’ To Approve Novel Device

US FDA needs to speed up its approval procedures for review of revolutionary devices like the LUKE prosthetic arm, says its inventor Dean Kamen. The arm was launched by Mobius Bionics on July 8. Kamen took a few moments after testifying at a House robotics hearing to explain its capabilities to Medtech Insight and share his thoughts about the FDA device review process and the spirit behind the 21st Century Cures bill.

Regulation Innovation

OUS Approvals Analysis: Expanded CoreValve Indication And Zika IVDs Among August’s CE Marks

August was another slow month for announcements of medical device approvals outside the US, but the short list of non-US approvals this month includes a broad range of device-types approved, notably a much-awaited expanded indication for Medtronic’s CoreValve Evolut R, in six different territories.

Commercial Approvals

US Approvals Analysis: FDA Makes Efficiency Mark For PMAs

The US agency achieved its most efficient performance in the past 15 years for original PMA submission reviews in the most recently completed application cohort. PMA approval volumes also remain healthy. Meanwhile, 510(k) review times have leveled off and clearance volumes have dropped slightly.

Approvals Regulation

Rotation's Bioinductive Shoulder Implant Succeeds In Australian Trial

The device has 510(k) clearance for a broad tendon-repair indication, but the company is sponsoring clinical trials to further validate the technology, which induces new tissue growth around partially torn rotator cuffs rather than simply mechanically reattaching it.

Innovation Clinical Trials
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